Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

Medicare/NGS covers FDA-labeled drug uses and certain off-label uses when they meet the definition of a medically accepted indication supported by specified authoritative compendia, peer-reviewed literature, or NGS publications. Specific off-label approvals (e.g., bevacizumab for HHT with AVMs; eculizumab for biopsy-proven dense deposit disease; ibandronate for senile osteoporosis in males; infliximab for several refractory inflammatory conditions; selected LHRH analog and paclitaxel indications) are listed with required documentation, and coverage is contingent on the use being reasonable and necessary, route-appropriate, and consistent with the evidence and compendia criteria.

"A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI support..."